MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 28F; IMPLANT

Catalog Number 690-00-28F

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

It was reported that device in question would not sit with the matched cup.There was a 10 mins delay reported.The issue was rectified by using an alternate liner 690-10-22f.

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

The event was not confirmed.Visual inspection: the device was returned with the metal retaining ring dissociated from the body of the insert.Upon reassembly, it was noted that the ring fit loosely onto the insert.This is evidence to suggest that the device was processed through autoclave prior to return to stryker.No futher observations could be made of the returned device.Dimensional and functional inspection could not performed as the device exhibited evidence of being processed through autoclave prior to return to stryker, thus affecting the dimensions of the device.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.The event could not be confirmed nor the root cause determined as the returned device seems in pristine condition with out nicks or marks of implantation, the device appears that it was autoclave as the metal ring is dissociated from the insert and is loose fit.It is noted that the second liner which was used locked into the subject acetabular component successfully and the surgery was completed with no further complications.

Event Description

It was reported that device in question would not sit with the matched cup.There was a 10 mins delay reported.The issue was rectified by using an alternate liner 690-10-22f.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 28F
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4290156
• MDR Text Key: 5083526
• Report Number: 0002249697-2014-04493
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K061654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 690-00-28F
• Device Lot Number: MMPKVK
• Other Device ID Number: STERILE LOT# MSLMR27A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other